Precision Intratumoral Delivery of DNX-2401 with the Alcyone MEMS Cannula

HOUSTON and LOWELL, Mass., April 24, 2017 /PRNewswire/ -- DNAtrix, a clinical stage biotechnology company developing virus-based immunotherapies for cancer, and Alcyone Lifesciences, a leader in neural intervention systems and advanced drug delivery, will reveal clinical data demonstrating the precise administration of DNX-2401, an oncolytic adenovirus, into brain tumors using Alcyone's MEMS Cannula (AMCTM) at the Annual Meeting of the American Association of Neurological Surgeons (AANS) in Los Angeles, CA.

Neurosurgeon Frederick Lang, MD, FACS, FAANS, will present results from a Phase 1b study confirming reproducible delivery of DNX-2401 by the AMC into recurrent glioblastoma tumors. Infusion accuracy was determined using the "aura method," the displacement of DNX-2401 by gadolinium.

DNX-2401 is a potent oncolytic adenovirus that replicates in tumors and activates an anti-tumor immune response. The AMC is a dual-channel, MRI-safe cannula with the smallest-in-class micro-tip, ensuring optimal and consistent drug distribution while eliminating backflow.

"The AMC cannula standardizes the efficient delivery of DNX-2401 into the tumor of patients with recurrent glioblastoma," said Frank Tufaro, PhD, CEO of DNAtrix. "Based on these results, neurosurgeons in the US and Canada are using the AMC in our Phase 2 clinical trial of DNX-2401 with pembrolizumab (KEYTRUDA®)."

"The lessons learned from more than a decade of attempts at exploiting convection enhanced delivery (CED) for brain cancer treatment weighed critically on the design, development, and implementation of the AMC delivery platform. The drawbacks centered around sub-optimally designed devices that have poor bio-distribution characteristics as well as surgeons' inability to monitor the distribution of these drugs within the tumor," said PJ Anand, CEO of Alcyone Lifesciences. "It is our vision that the AMC intraparenchymal delivery platform will make this modality of treatment a permanent addition to clinical management of brain malignancies."

For more information about DNAtrix clinical studies administered with the AMC, please visit the ClinicalTrials.gov website: NCT02798406 (DNX-2401 with pembrolizumab) and NCT02197169 (DNX-2401 with/without interferon gamma).

About DNX-2401

DNX-2401 is an investigational oncolytic immunotherapy designed to treat cancer. DNX-2401 sets off a chain reaction of tumor cell killing by selectively replicating within tumor cells for a period of weeks to months while sparing normal cells then secondarily triggering an anti-tumor immune response directed against the tumor. DNX-2401 has been well tolerated in patients with recurrent glioblastoma and survival has been prolonged compared to other therapies.

About Alcyone's MEMS Cannula (AMC) Targeted Delivery System

The Alcyone MEMS Cannula Targeted Delivery System was developed using the company's proprietary microelectromechanical system (MEMS) technology platform. Without burdening the neurosurgery community with unnecessary additional capital equipment, the AMC can be utilized with any existing commercial imaging and stereotactic system in conjunction with the work-flow friendly clinical use guideline designed by the company's scientist and neurosurgery advisors. Under intra-procedural MRI guidance, neurosurgeons can select a target, navigate the AMC precisely, and observe precision delivery of the therapeutic agent in real time. In addition to the MEMS tip, which has dual micro-channels, the AMC features a unique patented distal end design that helps prevent reflux or back flow along the cannula shaft. This can be a significant drawback with current devices. The AMC platform device is designed for optimal targeted bio-distribution and neurosurgeon's ease of use.

About DNAtrix

DNAtrix is a privately held, clinical stage, biotechnology company developing virus-driven immunotherapies for cancer. DNAtrix's lead product, DNX-2401, is a conditionally replicative oncolytic virus being evaluated in clinical trials for recurrent glioblastoma, a brain cancer for which there is neither a cure nor adequate treatment. The company is backed by Morningside Ventures and Mercury Fund, and has been awarded a grant from the Cancer Prevention and Research Institute of Texas (CPRIT). For more information, please visit the company website at www.dnatrix.com.

About Alcyone Lifesciences

Alcyone Lifesciences, based in Lowell, Massachusetts, is a privately-held medical device company focused on development of novel treatment modalities for difficult to treat chronic neurological conditions. The Company's patented technology platforms are based on a uniquely engineered amalgamation of microfabrication technologies along with advanced biomedical engineering. Its core products focus on intraparenchymal, intrathecal, and intra-vascular advanced drug therapy, along with the treatment of hydrocephalus. Alcyone's team of scientists, physicians, and advisors includes recognizable leaders in the field of neurology and neurosurgery. For more information, please visit www.alcyonels.com.